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Use of Ex-vivo Hypotermic Perfusion in Patients with Hepatocellular Carcinoma Candidates for Liver Transplant to Reduce the Incidence of Tumor Recurrence
This is a retrospective study of single-center cohorts that involves patients with HCC who underwent liver transplantation between January 2016 and 2021, who received livers preserved with Hypothermic Oxygenated Perfusion (HOPE) or Static Cold Storage (SCS) with a minum follow up of 12 months.
The gold standard treatment for Hepatocellular Carcinoma (HCC) is Liver Transplantation (LT) but, despite its success, it maintains cancer recurrence rates of 16%. Ischemia-reperfusion injury (IRI) is considered a major determinant of the higher rate of HCC recurrence associated with transplantation from ECD donors and/or organs with ischemic damage. In this field, the treatment with Machines Perfusion (MP) of the liver has gained increasing attention in the transplant community as a useful tool to relieve IRI, test the hepatic function before transplantation and potentially reconditioning the marginal organs. The current study aims to show that Hypothermic Oxygenated Perfusion (HOPE) can protect recipients not only from IRI and post-transplant complications but also from tumour recurrence, which appears to be inevitably linked to the quality of the organ. This will be done through the comparison between a retrospective group of patients with HCC who have undergone LT with graft preserved by HOPE and a retrospective group of HCC recipients who received grafts preserved without perfusion, but with Static Cold Storage (SCS) technique.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy
Start Date
June 3, 2022
Primary Completion Date
January 8, 2024
Completion Date
January 8, 2024
Last Updated
January 30, 2025
237
ACTUAL participants
Hypothermic Oxygented Perfusion
PROCEDURE
Static Cold Storage
PROCEDURE
Lead Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT06349642
NCT07233096
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